The Compliance Pivot
Why you must stop calculating ROI based on “lost asset recovery” and start evaluating based on “audit readiness” and “risk reduction.”
eBook
Real-Time Location Systems (RTLS) for FDA QMSR Compliance in 2026
Using RTLS to Automate Compliance for FDA’s New QMSR Regulations for Medical Device Manufacturers and Pharmaceutical Industries
Real-Time Location Systems (RTLS) for FDA QMSR Compliance in 2026
Author : Petr Sedlacek
For Medical Device Manufacturers and Pharmaceutical Industries
Is Your Facility 'Audit-Ready' after 02 February 2026 Deadline?
After the critical date of 02 February 2026 - enforcement date for the FDA’s new Quality Management System Regulation (QMSR), the medical device and pharmaceutical industries face a harsh reality: Manual systems can no longer keep up.
While standard RTLS information focuses on warehouse efficiency, they miss the bigger picture. In a regulated environment, knowing where an asset is isn't enough!
You need objective evidence of its history, condition, and chain of custody.
In this exclusive eBook, "Real-Time Location Systems (RTLS) for FDA QMSR Compliance in 2026," Petr Sedlacek challenges the industry to stop viewing RTLS as a simple asset tracker and start treating it as the foundational infrastructure for Automated Compliance.
What’s Inside
QMSR & Traceability
How to satisfy the new record control requirements (§820.35) by replacing static spreadsheets with dynamic, real-time data streams.
The eQMS Handshake
A technical roadmap for feeding RTLS data directly into your Electronic Quality Management System to close the loop between physical operations and digital records.
Q1 2026 Implementation Strategy with RTLS
How to satisfy the new record control requirements (§820.35) by replacing static spreadsheets with dynamic, real-time data streams.
Essential compliance
Comes complete with essential compliance checklists for you to assess if your site’s ‘audit-ready’ or at risk!